Article Figures & Data
Figures
- Figure 1.
Enrolled vs activated practices in the HOMER study (September 2021-November 2023).
HOMER = Home versus Office for Medication Enhanced Recovery.
- Figure 2.
Comprehensive cohort study design in HOMER.
HOMER = Home versus Office for Medication Enhanced Recovery; OUD = opioid use disorder.
Tables
What Happened? How Did It Impact the Study? What Did We Do? COVID-19 declared a worldwide pandemic Original plan for a large, in-person kick-off meeting cancelled
Original plan for in-person practice recruitment and training cancelled
Rapid decline in in-person clinical visits
Practices struggling with revenue and financial survival unable to take on new or additional work
Delayed patient recruitment 4 months
Extended practice and patient recruitment window
Rather than 1 initial kick-off, offered flexible start “windows,” initially in waves of multiple practices and then eventually single practice starts
Allowed more practice types, not just single-specialty primary care practices
Rapid expansion and reliance on telehealth Practices stressed with need to rapidly deploy telehealth
Given the 2-arm randomized study design comparing home and office induction, patients starting treatment with a telehealth induction protocol were ineligible and could not participate
Expanded the original 2-arm study design (home vs office) to a 3-arm study design (home vs office vs telehealth)
Conducted extensive conversations with funder and project officer; changed total number of participants (new power calculation: 1,200 participants for 3 arms)
Fewer prescriptions for opioids, so fewer potential patients with OUD in the practice Decreased opportunity to identify patients in the practice who might have OUD
More difficult to identify OUD
Low patient enrollment
Created comprehensive patient recruitment materials
Created practice materials (website template, portal templates, EHR “dot phrases,” EHR search terms, medication and refill messages)
Created other materials (newspaper articles, outreach to community organizations)
Rapid increase in fentanyl analogues in community Fewer patients seeking refills on prescription opioids
Increased overdose deaths
Increase in new and emerging drugs combined with opioids
Disseminated community messages, newspaper articles with local clinician quotes
Conducted clinical education for practices
Provided additional training on MOUD treatment protocols
Included “microdosing” and bridge dosing protocols
COVID-19 waves alpha, delta, omicron Clinician burnout leading to a decline in participation
Practice burnout leading to withdrawal from study or decline in participation
Low practice engagement
Low rate of practice survey completions
Attended to “care and feeding” of practices
Instituted more robust communication and engagement; offered regular newsletters, regular optional “drop-in” video calls
Tailored practice feedback reports
Offered survey completion incentives
Developed a StoryMapa
Conducted in-person and virtual site visits
Gave out practice care packages
Patient or clinician preference for induction method Patients who were unwilling to be randomized to induction method (home, office, telehealth), or whose clinician chose the method, were not eligible to participate
Modified the study design
Converted to the comprehensive cohort study design with parallel enrollment into a randomized component and a nonrandomized, patient preference component
Ongoing primary care struggles of low payment, COVID, consolidation, shrinking workforce, and work overload Clinician burnout
Practice burnout
Increased frequency of contact with practices—practice support
Conducted ongoing practice recruitment
Modified (lowered) enrollment goals
Extended patient enrollment 9 months
“Fourth wave” of opioid epidemic: multiple drug use with cocaine, benzodiazepines, methamphetamine, xylazine Patients were less likely to present for care
Practices struggled with treatment options other than buprenorphine because patients had more than just opioid dependence, affecting patient care and also eligibility for the study
Conducted regular educational webinars for clinicians and practice staff
Focused on buprenorphine for OUD, referral to additional services for other drug use
EHR = electronic health record; HOMER = Home versus Office for Medication Enhanced Recovery; MOUD = medication for opioid use disorder; OUD = opioid use disorder.
↵a StoryMaps offer an engaging multimedia format to disseminate research findings, study stories, and participant voices. We used ArcGIS StoryMaps, an app within the ArcGIS system (Esri), to organize audio/visual content into a StoryMap.
Practice Orientation Wave Dates No. of Practices No. of Practice Staff 1 April 28 and May 5, 2021 30 85 2 July 8 and 14, 2021 18 41 3 September 2 and 8, 2021 14 31 4 November 9, 11, and 19, 2021 5 7 5 February 16, 2022 2 6 Total 69 170 HOMER = Home versus Office for Medication Enhanced Recovery.
Domain Lesson Destination Keeping our focus on the most important element—helping patients with opioid use disorder—as we were reminded by our patient and community advisory groups Relationship Attending to the care and feeding of our research team, participating practices, and advisory groups Listening Listening to patients, study participants, clinicians, practice staff, advisory groups, research team, community, media Flexibility Balancing changes to the protocol with scientific rigor and fidelity to the research plan with a focus on the destination Communication Ensuring bidirectional dialog among research staff, practices, patients and study participants, advisory groups; proactive and responsive
PLAIN LANGUAGE ARTICLE SUMMARY
Special Report
Adapting Opioid Treatment Research Amid COVID-19: The Resilient Journey of the HOMER Study
Background and Goal: The HOMER study was launched to determine the most effective setting for starting buprenorphine treatment for opioid use disorder. Originally designed as a randomized trial comparing home-based versus office-based inductions, the study faced significant challenges due to the COVID-19 pandemic. These included shifts in health care delivery, changes in patient preferences, and the emergence of new practices like telehealth. The goal was to adapt the study to these unprecedented circumstances while maintaining its focus on patient-centered care and effective treatment outcomes.
Key Insights:The HOMER study had to quickly adapt to the unprecedented challenges brought on by the COVID-19 pandemic. Researchers could have made decisions regarding study design purely from a methodological perspective, but they chose to engage the community in decision making. With community input, the study design evolved to include a third arm, telehealth, in response to the rapid shift in health care delivery methods. As the study progressed, it became clear that both patients and clinicians had strong preferences for specific induction methods. This led to an additional significant change in the study’s design, shifting from a purely randomized approach to a comprehensive cohort design. This change allowed the study to accommodate patients who preferred not to be randomized. Despite the numerous challenges, including recruitment delays and shifts in health care priorities, the HOMER study persisted. As of January 2024, HOMER has enrolled nearly 300 study participants, and practices are still participating.
Why It Matters: The experiences and adaptations of the HOMER study shows how research can remain resilient and responsive in the face of unforeseen challenges. Flexibility in research design and active engagement with patients, clinicians, and community advisors can keep studies relevant and patient-centered. The challenges overcome by the research team offer valuable lessons for other researchers, highlighting the importance of adaptability, collaboration, and perseverance in achieving meaningful outcomes, particularly in fields like opioid use disorder treatment.
The Odyssey of HOMER: Comparative Effectiveness Research on Medication for Opioid Use Disorder During the COVID-19 Pandemic
Linda Zittleman, MSPH, et al
University of Colorado Department of Family Medicine, Aurora, Colorado
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